Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2

Near-infrared Spectroscopy, Transition, Caesarean Section Clinical Trial

Official title:

Cerebral Oximetry in Newborns - Comparing INVOS 5100c and OxyPrem vs. 1.2's Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771601
• Other study ID #: 090113OXYVOS
• Status: Completed
• Phase: N/A
• First received: January 16, 2013
• Last updated: September 30, 2013
• Start date: January 2013
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The regional Danish ethical committeeDenmark: The Danish Data protection agency
• Study type: Observational

Clinical Trial Summary

Regional tissue oxygenation (cStO2) can be monitored by near infrared spectroscopy. The commercial device INVOS 5100 (COVIDIEN, Mansfield, MA, USA) and the prototype OxyPrem vs. 1.2 (Biomedical Optics Research Laboratory, Zurich, Switzerland) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective caesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. The Adult Somasensor (INVOS) will be used together with the OxyPrem sensor.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 10 Minutes

Eligibility

Inclusion Criteria:

• Term infants

• Elective caesarean section

Exclusion Criteria:

• Thick hair that makes good measurements difficult/impossible

• obvious malformations or syndromes

• Complications in relation to caesarean section

• Depression after birth (APGAR < 8 after 1 minute)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Near-infrared Spectroscopy, Transition, Caesarean Section

Locations

Country	Name	City	State
Denmark	Gorm Greisen	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Augustinus Foundation, Denmark.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxygenation	The sensors of both instruments will be placed on each side of the head. They will be held by hand by self-adhesive tape as appropriate.	10 minutes	No
Secondary	Reproducibility	The sensor will be placed 6 times alternating on each frontoparietal region and held by hand, obtaining 30 seconds of signal for each placement. The placements will be in the same region but not in exactly the same spot. This will be done for both devices.	10 minutes	No